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A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rebif®
Avonex®
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Relapsing-remitting Multiple Sclerosis, Rebif®, Avonex®, interferon-beta-1a

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 55 years Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria Two or more relapses within the preceding 24 months Clinical stability or improving neurological state during the 4 weeks before Study Day 1 Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI Willingness and ability to comply with the protocol for the duration of the study Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized) Exclusion Criteria: Secondary progressive MS, primary progressive MS or progressive relapsing MS Prior use of interferon Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI Psychiatric disorder that is unstable or will preclude safe participation in the study Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1 Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1 Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1 Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone Previous use of cladribine or total lymphoid irradiation Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA) Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1 Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rebif®

    Avonex®

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of exacerbation-free subjects
    Percentage of exacerbation-free subjects
    Percentage of exacerbation-free subjects

    Secondary Outcome Measures

    Mean number of combined unique (CU) active lesions per subject per scan
    Total exacerbation count per subject
    Mean Number of Time constant 2 (T2) active lesions per subject per scan

    Full Information

    First Posted
    February 13, 2006
    Last Updated
    August 2, 2013
    Sponsor
    EMD Serono
    Collaborators
    Merck Serono International SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00292266
    Brief Title
    A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)
    Official Title
    An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1999 (undefined)
    Primary Completion Date
    June 2002 (Actual)
    Study Completion Date
    June 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMD Serono
    Collaborators
    Merck Serono International SA

    4. Oversight

    5. Study Description

    Brief Summary
    This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Relapsing-Remitting
    Keywords
    Relapsing-remitting Multiple Sclerosis, Rebif®, Avonex®, interferon-beta-1a

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    677 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rebif®
    Arm Type
    Experimental
    Arm Title
    Avonex®
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Rebif®
    Intervention Description
    Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Avonex®
    Intervention Description
    Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.
    Primary Outcome Measure Information:
    Title
    Percentage of exacerbation-free subjects
    Time Frame
    Week 24
    Title
    Percentage of exacerbation-free subjects
    Time Frame
    Week 48
    Title
    Percentage of exacerbation-free subjects
    Time Frame
    Week 72
    Secondary Outcome Measure Information:
    Title
    Mean number of combined unique (CU) active lesions per subject per scan
    Time Frame
    Week 24
    Title
    Total exacerbation count per subject
    Time Frame
    Week 24, 48 and 72
    Title
    Mean Number of Time constant 2 (T2) active lesions per subject per scan
    Time Frame
    Week 24, 48 and 72

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 55 years Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria Two or more relapses within the preceding 24 months Clinical stability or improving neurological state during the 4 weeks before Study Day 1 Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI Willingness and ability to comply with the protocol for the duration of the study Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized) Exclusion Criteria: Secondary progressive MS, primary progressive MS or progressive relapsing MS Prior use of interferon Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI Psychiatric disorder that is unstable or will preclude safe participation in the study Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1 Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase [AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1 Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1 Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone Previous use of cladribine or total lymphoid irradiation Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA) Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1 Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gordon Francis, M.D.
    Organizational Affiliation
    Merck Serono International SA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mslifelines.com
    Description
    Full FDA approved prescribing information can be found here

    Learn more about this trial

    A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

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